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Terminated

AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.

FDA Recall Z-1151-2018 · Posted None

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2018-01-18
Date Terminated2023-09-27
Product Quantity73 units in US

Reason for Recall

A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips.

Firm Action

A recall notification letter was sent to affected US consignees on 1/19/2018 notifying them of the issue. In addition, the recalling firm is instructing field service engineers to inspect the tip present sensor for misalignment at the next service visit.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution. US nationwide, Algeria, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Macao, Mayotte, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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